ObjectiveTo investigate the expression levels of miR-128-3p， SIRT1， and AMPK in the peripheral blood of patients with type 2 diabetes mellitus （T2DM） comorbid with nonalcoholic fatty liver disease （NAFLD）， as well as the role of miR-128-3p in predicting NAFLD in T2DM patients. MethodsA total of 80 patients with T2DM who were hospitalized in The First Affiliated Hospital of Anhui University of Chinese Medicine from September 2022 to August 2023 were enrolled and divided into T2DM group with 40 patients and NAFLD group with 40 patients， and according to the NAFLD fibrosis score （NFS）， the patients were further divided into progressive liver fibrosis group with 16 patients and non-progressive liver fibrosis group with 64 patients. General data and biochemical parameters were collected； quantitative real-time PCR was used to measure the mRNA expression levels of miR-128-3p， SIRT1， and AMPK in peripheral blood， and Western blot was used to measure the protein expression levels of SIRT1 and AMPK. The independent-samples t test was used for comparison of normally distributed data between two groups， and the Mann-Whitney U test was used for comparison of data with skewed distribution between two groups； the chi-square test was used for comparison of categorical data between two groups. The logistic regression analysis was used to identify the influencing factors for the presence of NAFLD and progressive liver fibrosis， and the receiver operating characteristic （ROC） curve analysis was used to determine the optimal cut-off value of miR-128-3p for predicting NAFLD. ResultsThere were significant differences between the NAFLD group and the non-NAFLD group in body mass index， fasting plasma glucose， glycated hemoglobin， fasting insulin， fasting C-peptide， alanine aminotransferase （ALT）， aspartate aminotransferase， gamma-glutamyl transpeptidase， alkaline phosphatase， fibronectin， triglycerides， high-density lipoprotein cholesterol， total triiodothyronine （TT3）， Homeostasis Model Assessment of Insulin Resistance （HOMA-IR）， and NFS （all P<0.05）. Compared with the non-NAFLD group， the NAFLD group had a significantly higher mRNA expression level of miR-128-3p in peripheral blood （t=-8.765， P<0.001） and significant reductions in the mRNA and proteins expression levels of SIRT1 and AMPK （P<0.001）. There were significant differences between the progressive liver fibrosis group and the non-progressive liver fibrosis group in age， ALT， free triiodothyronine， TT3， superoxide dismutase， and miR-128-3p （all P<0.05）. The logistic regression analysis showed that miR-128-3p was an independent risk factor for the development of NAFLD （odds ratio ［OR］=8.221， 95% confidence interval ［CI］： 2.735 — 24.714， P<0.001） and progressive liver fibrosis （OR=1.493， 95%CI： 1.117‍ ‍—‍ ‍1.997， P=0.007）. The ROC curve analysis showed that miR-128-3p had an area under the ROC curve of 0.890 （95%CI： 0.829 — 0.950）， with an optimal cut-off value of 13.165， a sensitivity of 89.3%， and a specificity of 72.7%. ConclusionThere is an increase in the expression of miR-128-3p in peripheral blood of T2DM patients with NAFLD， while there are reductions in the expression levels of SIRT1 and AMPK， suggesting that miR-128-3p has a certain diagnostic value in identifying NAFLD and liver fibrosis in such population.

Objective:To develop and validate a Self-care Ability Scale for Arteriovenous Fistula (AVF) in Maintenance Hemodialysis (MHD) patients.Methods:Guided by Orem's self-care theory, the initial item pool of the scale was developed through a literature review, semi-structured interviews, and group discussions. The initial scale was finalized after two rounds of expert consultation using the Delphi method. A convenience sampling method was used to recruit 418 MHD patients using AVF in January 2024 for item analysis, exploratory factor analysis and reliability testing. Another 293 MHD patients using AVF were recruited in March 2024 for confirmatory factor analysis.Results:The self-care ability scale for AVF in MHD patients included four dimensions: knowledge and skills of AVF self-care, willingness and attitude toward AVF self-care, recognition and prevention of AVF complications, and patient self-adjustment and adaptation, comprising 38 items. The content validity index at the scale level was 0.98. Exploratory factor analysis extracted four common factors with a cumulative variance contribution rate of 84.706%. Confirmatory factor analysis indicated good model fit, strong convergent validity, and ideal discriminant validity. The total Cronbach's α coefficient of the scale was 0.987; the split-half reliability coefficient was 0.902, and the test-retest reliability coefficient was 0.979.Conclusions:The Self-care Ability Scale for AVF in MHD patients demonstrates excellent reliability and validity, making it a suitable tool for assessing patients' ability to self-care for their AVF.

Objective:To develop and validate a Self-care Ability Scale for Arteriovenous Fistula (AVF) in Maintenance Hemodialysis (MHD) patients.Methods:Guided by Orem's self-care theory, the initial item pool of the scale was developed through a literature review, semi-structured interviews, and group discussions. The initial scale was finalized after two rounds of expert consultation using the Delphi method. A convenience sampling method was used to recruit 418 MHD patients using AVF in January 2024 for item analysis, exploratory factor analysis and reliability testing. Another 293 MHD patients using AVF were recruited in March 2024 for confirmatory factor analysis.Results:The self-care ability scale for AVF in MHD patients included four dimensions: knowledge and skills of AVF self-care, willingness and attitude toward AVF self-care, recognition and prevention of AVF complications, and patient self-adjustment and adaptation, comprising 38 items. The content validity index at the scale level was 0.98. Exploratory factor analysis extracted four common factors with a cumulative variance contribution rate of 84.706%. Confirmatory factor analysis indicated good model fit, strong convergent validity, and ideal discriminant validity. The total Cronbach's α coefficient of the scale was 0.987; the split-half reliability coefficient was 0.902, and the test-retest reliability coefficient was 0.979.Conclusions:The Self-care Ability Scale for AVF in MHD patients demonstrates excellent reliability and validity, making it a suitable tool for assessing patients' ability to self-care for their AVF.

ObjectiveTo evaluate the methodological and reporting quality of clinical practice guidelines for Chinese patent medicine （CPM） with internationally recognized tools the appraisal of guidelines for research and evaluation （AGEREE） Ⅱ and reporting items for practice guidelines in healthcare （RIGHT）， thereby providing refe-rence for the clinical application and future development of CPM guidelines. MethodsDatabases including CNKI， VIP， Wanfang and Sinomed were searched for CPM guidelines， as well as medlive.cn， websites of China Association of Chinese Medicine and Chinese Medical Association， and reference lists of the included papers. The quality of the guidelines was evaluated using the AGREE Ⅱand RIGHT tools， and consistency tests were performed using Interclass Correlation Coefficient， and descriptive analysis and chi-square test were used to analyze the reporting rate for each domain and the average score for each item. ResultsFinally， 140 CPM guidelines were included， of which 51 were disease-oriented and 89 were drug-oriented， all of which were issued by China. For 51 disease-oriented CPM guidelines， the highest average score of all six AGREE Ⅱ domains was 73.32% for clarity， and the lowest was 26.80% for application； for 89 drug-oriented CPM guidelines， the highest average score was 55.62% for scope and purpose， and the lowest was 31.32% for rigour of development. In terms of the seven domains of the RIGHT checklist， the highest reporting rate was 68.26% for background， and lowest was 27.45% for other areas regarding the disease-oriented CPM guidelines； the highest reporting rate was 61.31% for background， and the lowest was 4.49% for other areas regarding drug-oriented CPM guidelines. The average reporting rate was higher for disease-oriented than drug-oriented CPM guidelines in three domains of AGREE Ⅱ （rigour of development， clarity of presentation， editorial independence）， as well as four domains of RIGHT checklist （basic information， evidence， funding and declaration and management of interests， and other areas）. ConclusionThe overall methodology and reporting quality of the current CPM guidelines still need to be improved. It is recommended that future guideline development teams should strictly refer to the AGREE Ⅱ and RIGHT checklist， and take into account of the characteristics of CPM guidelines and relevant methodo-logical suggestions in the development and reporting of CPM guidelines， thereby guiding the clinical use of CPM in a better way.

Objective:To assess the clinical efficacy and safety of image-guided γ-ray stereotactic body radiation therapy(IG γ-SBRT)in treating advanced pancreatic cancer.Methods:A total of fifty-six patients with advanced pancreatic cancer admitted to Senior Department of Oncology Medicine of the Fifth Medical Center of Chinese PLA General Hospital(Department of Oncology of the Sixth Medical Center)from February 2017 to September 2020 were selected.All patients were treated with IG γ-SBRT,and the 50%-60%of isodose curve covered the planned target volume(PTV).The peripheral dose of each time was 3.0-4.5 Gy,and there were 10-11 times of treatment.The therapeutic effect was observed and was evaluated by follow-up.The visual analog scale(VAS)score was adopted to assess the situation of the pain of patients before and 3 months after treatment,and the adverse reaction of them.Results:In the 56 patients,52 cases occurred epigastric pain with VAS ranging from 3 to 10 points,among which 32 patients accompanied by symptoms such as lower back pain and abdominal distension.After 3 months of treatment,the results of reexamination and follow-up indicated that there were 48 patients whose VAS scores decreased 3 scores and above 3 scores on the basis of original scores,and the efficiency of treating pain was 92.3%.In addition,the VAS scores of 3 patients decreased 1-2 scores on the basis of original scores,which ratio was 5.85%of the total number of people.All 56 patients were reexamined at the 3rd month after treatment,and 13 cases of them obtained complete response(CR),and 37 cases obtained partial response(PR),and 1 case obtained progressive disease(PD),and 5 cases obtained stable disease(SD),and the objectively response rate(ORR)was 89.3%,and the locally control rate was 98.2%.In addition,median progression-free survival(PFS)was 6.5 months,and 1-year survival rate was 62.5%(35/56),and 2-year survival rate was 23.2%(13/56).The adverse reactions of 56 patients were the adverse reactions of digestive system and blood system,among which 47 patients occurred upper digestive tract reaction,and the incidence of adverse reactions was 83.9%(47/56).A total of 43 patients occurred myelosuppression,and the incidence of myelosuppression was 76.8%(43/56).Conclusion:IG γ-SBRT can effectively relieve the symptoms of metastatic pancreatic cancer,and improve the effectiveness of treatment,the local control rate and survival rate.The tolerance of adverse reaction of that is favorable,and the safety of that is higher.

In February 2023, the National Health Commission, together with the Ministry of Science and Technology, the Ministry of Education, and the State Administration of Traditional Chinese Medicine issued the Ethical Review Measures for Life Science and Medical Research Involving Humans, which emphasizes that research participants involving vulnerable groups such as children, intellectual disabilities, and mental disabilities should be given special protection. This paper expounded the current situation of protecting vulnerable groups from six aspects: inadequate protection of vulnerable groups by relevant laws and regulations, unclear definition of vulnerable groups, insufficient supervision by relevant departments, insufficient review ability of ethics committee to satisfy the protection of vulnerable groups, difficulty in fair inclusion of vulnerable groups, and the need to improve the ethical awareness of researchers and vulnerable groups. This paper also analyzed the new requirements for the protection of vulnerable groups in the Ethical Review Measures for Life Science and Medical Research Involving Humans from the following three aspects: expanding attention to potentially vulnerable research participants, paying more attention to the consent of research participants without or with limited capacity for civil conduct, and re-informed consent after the improvement of civil capacity level. Finally, suggestions on strengthening the protection of vulnerable groups were put forward from six aspects: improving the relevant legal system, clarifying the category of vulnerable groups, strengthening the implementation by regulatory departments, establishing a research participant protection system by research institutions, improving the ethical review capacity of ethics committees, formulating review guidelines by industry associations, and strengthening the education and training of all parties, so as to minimize the risk of vulnerable groups participating in clinical research and boost the quality and speed of clinical research in China.

ObjectiveTo explore the beliefs and attitudes about sleep in patients with comorbid depressive disorder and insomnia， and to explore its influence on sleep quality. MethodsPatients with comorbid depressive disorder and insomnia （n=61） and patients with primary insomnia （n=62） who met criteria specified in the Diagnostic and Statistical Manual of Mental Disorders， fourth edition （DSM-IV） in Beijing Anding Hospital Affiliated to Capital Medical University were enrolled， meantime， another 64 healthy controls were recruited. All subjects were assessed using Dysfunctional Beliefs and Attitudes about Sleep （DBAS） and Pittsburgh Sleep Quality Index （PSQI）. Additionally， patients with comorbid depressive disorder and insomnia were evaluated using Hamilton Depression Scale-17 item （HAMD-17）. The PSQI and DBAS scores were compared among three groups using analysis of covariance， and multiple linear regression analysis was used to screen the factors affecting PSQI score in patients with comorbid depressive disorder and insomnia. ResultsCompared with healthy controls， higher scores of PSQI （t=18.932， 18.610， P<0.01） along with lower scores of DBAS （t=-5.561， -5.791， P<0.01） were observed in patients with comorbid depressive disorder and insomnia and patients with primary insomnia. Taking the PSQI score of patients with comorbid depressive disorder and insomnia as the dependent variable， statistically significant equations were generated using multiple linear regression analysis （F=14.095， R²=0.327， P<0.05）， and the predictive and control factors of sleep in DBAS and age were found to be the influencing factors of PSQI score in patients （B=-0.100， -0.279， P<0.05 or 0.01）. ConclusionCompared with the normal，depression patients with insomnia have more dysfunctional beliefs and attitudes towards sleep，and dysfunctional cognition may be the influencing factor of their sleep quality.

OBJECTIVE： To e stablish modified aqueous two-phase extraction （ATPE） system of polyphenols from Archidendron clypearia. METHODS ：Taking the polyphenol content ，extraction efficiency and partition coefficient of A. clypearia as indexes ，the solid-liquid ratio ，ethanol mass fraction and ultrasonic time of ATPE system were selected by single factor tests . The aqueous two-phase extracts from different polar parts of A. clypearia was prepared. The modifier was selected by taking polyphenol content and antioxidant activity [IC 50 of 1，1-diphenyl-2-trinitrophenylhydrazine （DPPH）， 2，2′-hydrazine bis （3-ethylbenzothiazole-6-sulfonic acid ） diammonium salt （ABTS）] as indicators ，combined with the grey correlation analysis between polyphenols and antioxidant activity. The effects of modified ATPE system with different mass fraction （0-90％）of modifier on the extraction of polyphenols from A. clypearia were investigated and compared with traditional extraction technology （ultrasonic extraction and heating reflux extraction ）. RESULTS ：The optimal ATPE system included solid-liquid ratio of 1 ∶ 45， ethanol mass fraction of 40％，（NH4）2SO4 mass fraction of 11％，ultrasonic extraction time of 20 min，at room temperature. In 3 validation tests ，polyphenol content ，extraction efficiency and partition coefficient were （28.35±1.01）％（RSD＝3.56％，n＝3）， （98.87±0.19）％（RSD＝0.19％，n＝3）and 13.25±0.71（RSD＝5.39％，n＝3），respectively. The modifier was ethyl acetate. When the mass fraction of ethyl acetate in the ethyl acetate-ethanol mixed solvent was 70％，there was no significant difference in the content and anti-oxidant activity of polyphenols from A. clypearia of modified ATPE （P＞0.05）. The yield and transfer rate of it were si gnificantly higher than those of ultrasonic extraction and heating reflux extraction （P＜0.05）. CONCLUSIONS ：The modified ATPE system with better extraction yield and transfer rate than the traditional extraction technology is successfully established，which can extract polyphenols from A. clypearia 1048214903@qq.com in one step.

Objective:To explore the correlations among coping style, self-consistency and stigma in bipolar disorder depression patients.Methods:From June 2017 to December 2018, this study selected 217 bipolar disorder depression inpatients of Department of Mental Health at a Class Ⅲ Grade A hospital in Taiyuan by convenience sampling. All of them were investigated with the general information questionnaire, Perceived Devaluation-Discrimination Scale (PDD) , Self-Consistency and Congruence Scale (SCCS) and the Simplified Coping Style Questionnaire (SCSQ) . Amos 22.0 was used to path analysis.Results:The scores of PDD, SCSQ and positive coping style and negative coping style were (30.92±6.41) , (101.54±16.99) , (21.63±6.46) and (13.36±5.03) respectively. Pearson correlation analysis showed that positive coping style of patients had negative correlations with the self-consistency and stigma ( r=-0.748, -0.655; P<0.01) ; negative coping style had positive correlations with the self-consistency and stigma ( r=0.553, 0.742; P<0.01) ; self-consistency had a positive correlation with the stigma ( r=0.763, P<0.01) . Mediating effect test showed that self-consistency only had partial mediating role between the negative coping style and stigma and the mediating effect accounted for 40.54% of the total effect. Conclusions:The negative coping style not only has a direct impact on the stigma in bipolar disorder depression patients, but also has an indirect impact on stigma by self-consistency. Medical staff can carry out intervention based on this path to reduce the stigma of bipolar disorder depression patients.

The treatment of recurrent head and neck cancers has improved from single modality interventions of surgery and radiation therapy alone to include combined modality therapy with surgery, chemotherapy and radiation. Combined therapy has led to improved local control and disease-free survival. New developments in radiation oncology such as intensity-modulated radiotherapy, brachytherapy, stereotactic radiosurgery, fractionated stereotactic radiotherapy, have helped to improve this outlook even further. These recent advances allow for a higher dose to be delivered to the tumor while minimizing the dose delivered to the surrounding normal tissue. This article provides an update of the new developments in radiotherapy in the management of previously-irradiated recurrent head and neck carcinoma.